This is a double-blind controlled study. Subjects were randomly allocated into two groups. Neither the subjects nor the investigators knew about the treatments received.
In order to keep the study double-blinded, one nurse who was not involved with the study was responsible for allocating the subjects and providing the treatments.
Electromagnetic devices consisted of:
1. Electromagnetic chairs consisting of 13 transmitters.
2. Electromagnetic beds consisting of 12 transmitters.
3. Other portable electromagnetic devices including H-shape devices fitted for shoulders, belts and footpads.
The placebo devices were identical with the real devices but did not carry any electromagnetic energy.
All subjects were treated by these devices on a daily basis for 6 continuous weeks. They received the treatments for about 2 to 3 times each day for 30 minutes each session.
This study was approved by Ethical Committee of Faculty of Medicine Ramathibodi Hostipal, Mahidol University. All 60 subjects were recruited from outpatients, Department of Orthopedics. Their ages were between 18 to 74 years old of both sexes.
They were generally healthy assessed by physical examinations and routine laboratory tests. These subjects suffered from degenerative diseases of musculoskeletal systems including degenerative and myofascial pain for at least 3 months. All subjects were explained in details about the study and their roles in participation.
They gave their written informed consents and had their rights to withdraw from the study any time they wish without losing their future rights to continue receiving treatments provided by the hospital.
All subjects received thorough physical examinations and routine laboratory tests in order to assess whether or not they would safely be treated with electromagnetic devices.
Patients who had metal insertions and were on pacemakers were not allowed to participate. Those who were diagnosed of having hypertension and diabetes mellitus and had not received any medical treatments were sent to internal medicine clinics to receive medical treatments before being eligible for the study.
On the study day, all subjects were treated for about half an hour by electromagnetic devices one hour after their breakfast. After that, repeated treatments were given after at least one hour rest. All subjects were evaluated for pain once a week. Complete evaluations were performed before, at 3 and 6 weeks after receiving the treatments.
Criteria for pain evaluation included pain intensity scores, pain relief scores, visual analog pain scores, total amounts of analgesics used and scores assessing quality of life.
After the study was completed, all subjects were asked to give their global ratings on electromagnetic therapy received and were reexamined by physical examinations and routine laboratory tests.
1. Pain Intensity Score classified into 4 levels
0 = no pain
1 = mild pain
2 = moderate pain
3 = severe pain
2. Pain Relief Score classified into 5 levels
0 = no pain relief
1 = less than half gone
2 = about half gone
3 = more than half gone
4 = complete pain relief
3. Visual Analog Pain Score
All subjects were asked to evaluate their pain intensity by marking on a straight line 10 cm. long having the phrases of "no pain" at one end and "most severe pain" at the other send.
4. Quality of Life Score classified into 4 levels
0 = no changes
1 = slight improvement
2 = moderate improvement
3 = a lot of improvement
5. Global ratings classified into 4 levels
1 = poor
2 = fair
3 = good
4 = very good
Assessments of efficacy of electromagnetic therapy in pain relief were assessed by:
1. Pain Intensity Score
2. Pain Relief Score
3. Visual Analog Pain Score
All pain parameters were calculated for means and standard deviations and further analysis statistically by using Student t-tests and Contingency Table Analyses to determine statistically differences between treated and control groups.
Data on quality of life and global rating scores were analysis by contingency table analysis.
Evaluation of safety of electromagnetic devices was done by comparing changes in heart rate, blood pressure and alterations in routine laboratory data before and after the treatments.
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